Clarithromycin therapy for patients with cystic fibrosis: a randomized controlled
trial.
Author(s): Robinson P, Schechter MS, Sly PD, Winfield K, Smith J, Brennan S, Shinkai M,
Henke MO, Rubin BK.
Affiliation(s): Department of Respiratory Medicine, Royal Children's Hospital, Murdoch Children's
Research Instutite, Australia. phil.robinson@rch.org.au
Publication date & source: 2012, Pediatr Pulmonol. , 47(6):551-7
The clinically significant actions of oral azithromycin in modifying progressive
cystic fibrosis (CF) lung disease have been well documented. In vitro and
clinical data suggests that clarithromycin has immunomodulatory properties
similar to other 14-member macrolides, however two previously reported short
term, open label trials of clairthromycin in small numbers of patients with CF
failed to show significant benefits in modifying lung function or inflammation.
We performed an international double blind, cross-over trial in which 63 subjects
with CF were studied while receiving either placeo or 500 mg oral clarithromycin
twice daily for 5 months, with a 1-month wash-out. The primary efficacy end point
was the change in lung function (FEV(1) and FVC) during the clarithromycin
treatment period compared to placebo treatment. Secondary efficacy end points
included; quality of life, number of pulmonary exacerbations, height and weight,
sputum inflammatory mediator content, sputum transportability and surface
properties, bacterial flora, nasal potential difference, and breath condensate.
No significant difference in either the primary efficacy end point or any
secondary end point was seen during the period of clarithromycin treatment
compared to those seen during placebo administration. We conclude that
clarithromycin is not effective in treating CF lung disease.
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